Clinical Trial 20561

• Overview

  Study Title:

  Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies

  Summary:

  This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections

  Objective:

  This study proposes to estimate the effectiveness of prolonged use (7 days) of NPWT in an oncologic setting. We plan to address the following aims: 1) To estimate the effectiveness rate of the NPWT dressing in decreasing wound infection for oncologic gastrointestinal surgical procedures; 2) To evaluate if usage of NPWT is associated with earlier return to intended oncologic therapy (RIOT) after surgical resections for gastrointestinal cancer; and 3) To test the difference in SSI between standard wound therapy versus NPWT in decreasing wound events after oncologic gastrointestinal procedure. We hypothesize use of the negative pressure dressing could decrease the incidence of postoperative infection complication (SSI) and possibly lead to faster initiation of antineoplastic therapy.

• Treatments

  Therapies:

  Therapy (NOS)

• Inclusion Criteria

  • >18 years of age
  • Scheduled surgical procedure for the management of gastrointestinal cancer
  • Scheduled surgical procedure planned for incision that will result in wound >5cm
  • Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil®
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

• Exclusion Criteria

  • Scheduled surgical procedure where wound considered dirty
  • Scheduled surgical procedure for wound left for closure by secondary intention
  • Emergency surgery
  • Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study
  • History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems

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